Pellizzaro 2013.

Study characteristics
Methods	Study design Parallel RCT Study dates Duration of follow‐up: 10 weeks Time frame: June to September 2009
Participants	Study characteristics Setting: single centre (dialysis unit of Santa Casa de Misericórdia, Porto Alegre, Rio Grande do Sul) Country: Brazil Inclusion criteria: 18 and 70 years; dialysis > 3 months; agree to participate by signing an informed consent form Exclusion criteria: unstable angina; uncontrolled cardiac arrhythmia; decompensated heart failure; SBP > 200 mm Hg; DBP > 120 mm Hg; acute pericarditis or myocarditis; decompensated DM (fasting serum glucose > 300 mg/dL); severe untreated mitral or aortic insufficiency/stenosis; severe lung conditions; acute systemic infection; severe bone disease; lower limb amputations; cognitive disorders; unable to perform the proposed tests due to disabling musculoskeletal, bone, or joint disorders Baseline characteristics Number (analysed/randomised): intervention group 1 (11/15); intervention group 2 (14/15); control group (14/15) Mean age ± SD (years): intervention group 1 (43 ± 13.8); intervention group 2 (48.9 ± 10.1); control group (51.9 ± 11.6) Sex (M/F): intervention group 1 (8/3); intervention group 2 (7/7); control group (8/6) Dialysis type: HD Median dialysis vintage, IQR (years): intervention group 1 (5, 2 to 11); intervention group 2 (4.5, 0.9 to 10); control group (4.5, 1 to 6.5) Comorbidities CVD: not reported Diabetes: not reported Hypertension: not reported Depression (clinician diagnosis): not reported
Interventions	Intervention classification Non‐pharmacological intervention Indication: study targeting fatigue Intervention group 1 Respiratory muscle training for 10 weeks Intervention group 2 Peripheral muscle training for 10 weeks Control group No intervention Co‐interventions All patients performed HD 3 times/week with a Tina machine (Baxter), with capillary filter size 10 L (Gambro). The standard prescription for the HD was blood flow rate at 300 mL/min, dialysate flow rate at 700 mL/min, and total dialysis session length of 4 hours Vascular access was through an arteriovenous fistula in all patients
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available HRQoL KDQOL‐SF (Appendix 3): assessed before and after 70 days Energy/fatigue Pain Sleep Symptoms/problems Change in maximal inspiratory pressure (PImax) Respiratory pressure metre: assessed before and at the end of the test Change in maximal expiratory pressure (PEmax) Respiratory pressure metre: assessed before and at the end of the test Forced vital capacity Spirometry: assessed before and at the end of the test Change in functional capacity 6MWT: assessed before and at the end of the test Kt/Vsp: assessed before and after training Subjective effort perception Borg scale: assessed before and at the end of the test Death: assessed until the end of treatment Vital signs (BP, heart rate, respiratory rate, peripheral oxygen saturation (SpO2)) Pulse oximeter: assessed before and after training Laboratory results (CRP, HCT, Hb, serum levels of urea, creatinine, potassium, phosphorus, albumin): assessed before and after 70 days
Notes	Additional information Funding: Research Funding of Hospital de Clínicas de Porto Alegre (FIPE/HCPA) Conflicts of interest/disclosures: none. The authors alone are responsible for the content and writing of the article Trial registration identification number: not reported A priori published protocol: protocol number 3087/09
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Randomisation was made by dividing the subjects into three blocks of 15 each, five in each group." Comment: Sequence generation methods were not reported in sufficient detail to permit judgement
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported in sufficient detail to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not reported. However, interventions were different and participants and/or investigators could be aware of the treatment assigned
Blinding of outcome assessment (detection bias) All outcomes	High risk	The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Of the 45 patients initially included, six did not complete the study protocol due to non‐compliance (n = 5) or death (n = 1) and were not included in the analysis." Comment: 11/15 participants in the intervention group 1 (respiratory muscle training), 14/15 participants in the intervention group 2 (peripheral muscle training), and 14/15 participants in the control group (no treatment) completed the study (> 5% lost to follow‐up, with differences between groups). Reasons for discontinuations seemed to be not related to the treatment allocation
Selective reporting (reporting bias)	High risk	Protocol was published. Fatigue was reported in accordance with a pre‐specified analysis plan, using multiple eligible outcome measurements (scales, time points). Fatigue was reported in a format that was extractable for meta‐analysis. However, objective and subjective outcomes were assessed. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias	Low risk	There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and authors had no conflicts of interest. The study seemed to be free from other source of bias